SUCTION COAGULATOR

K072559 · Megadyne Medical Products, Inc. · GEI · Oct 5, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K072559
• Device Name: SUCTION COAGULATOR
• Applicant: Megadyne Medical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

Device Story

Handheld electrosurgical device; conducts monopolar energy from electrosurgical generator (ESU) to target tissue; provides concurrent suction for removal of surgical smoke and fluids. Available in hand-controlled or foot-controlled configurations; supplied with holsters. Used in OR/clinical settings by surgeons/physicians. Single-use only. Benefits include simultaneous coagulation and site clearance, improving surgical visibility and efficiency.

Clinical Evidence

Bench testing only. Device conforms to ISO 60601-2-2:2006 (safety of high-frequency surgical equipment) and ANSI/AAMI HF 18-2001 (electrosurgical devices). No clinical data presented.

Technological Characteristics

Handheld electrosurgical instrument; monopolar energy delivery; integrated suction channel. Energy source: external electrosurgical generator (ESU). Standards: ISO 60601-2-2:2006, ANSI/AAMI HF 18-2001. Single-use. No software or electronic sensing components.

Indications for Use

Indicated for patients undergoing ENT or general surgical procedures requiring monopolar electrosurgical coagulation and fluid/smoke aspiration.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• MegaDyne Suction Coagulator (K946327)
• Valleylab Lectrovac (K791752)

Submission Summary (Full Text)

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# KO72559

#### 510(k) Summary Section 5

September 6, 2007

## A. Submitter's Name / Address

Ronda K. Magneson Director, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 [phone] [phone] fax

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OCT 5, 2007

#### B. Contact Person

Primary: Ronda K. Magneson Director of Regulatory Affairs / Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 [phone] [phone] fax

- Ihsan Samara Alternate: Quality Manager Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 [phone] [phone] fax
# C. Megadyne's Manufacturing Facility

Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 [phone] [phone] fax

Megadyne Medical Products, Inc. 510(k): Suction Coagulator

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K072559

## D. Device Name

Common Name:

Device, electrosurgical, cutting & coagulatio accessories

Trade Name:

Classification (if known):

21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories

# E. Predicate Devices

The predicate devices include the MegaDyne Suction Coagulator which was cleared for marketing via 510(k) # K946327 by FDA's Office of Device Evaluation on June-7, 1995; and Valleylab's Lectrovac which was cleared for marketing via 510(k) #K 791752 on October 4, 1979.

Suction Coagulator

# F. Applicant Device Description

The suction coagulator is a hand held electrosurgical device used for coagulation and aspiration during electrosurgical procedures. The device is available in two different configurations: hand controlled and foot controlled models. Both models are supplied with holsters.

# G. Applicant Device Intended Use

The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.

## H. Technological Characteristics

The proposed device shares the same technological characteristics found in the predicate devices. It is a handheld electrosurgical device used for coagulation and aspiration during electrosurgical procedures.

## I. Safety information

Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other suction coagulators on the market. There are no new technologies incorporated into the device.

Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices.

Megadyne Medical Products. Inc. 510(k): Suction Coagulator

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Megadyne Medical Products, Inc. % Ms. Ronda K. Magneson Director, Regulatory Affairs and Quality Assurance 11506 South State Street Draper, Utah 84020

OCT 5 2007

Re: K072559

Trade/Device Name: Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 06, 2007 Received: September 11, 2007

Dear Ms. Magneson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark A. Milliken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Section 4 Indications for Use Statement

KO 42559 510(k) Number (if known): Device Name: Suction Coagulator

Indications for use:

The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

10(k) Number

Megadyne Medical Products, Inc. 510(k): Suction Coagulator

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